AlphMol obtained approval from Chinese and American regulatory bodies for auto immune diseases treatment

Monday, June 2, 2025 @ 12:00 am

AlphMol obtained IND approval from both Chinese CDE and American FDA for the leading auto immune pipeline.

This drug candidate AM-001 is an oral small molecule, targeting MRGPRX2 receptor to treat different auto immune diseases including atopic dermatitis, urticaria and potentially others. AM-001 is a very safe drug candidate with the safety margin >600 folds in the GLP tox study in monkey. Its outstanding in vivo efficacies were verified by different animal models. Related clinical trial will be started soon.

About the target MRGPRX2
MRGPRX2 is a clinically proof-of-concepted G protein-coupled receptor which is on the surface of mast cell. It was distributed abandonly in the skin, adipose tissue as well as intestinal tract. The receptor is activated by a broad spectrum of ligands that are prevalent during inflammation. Targeting MRGPRX2 has great potential across an array of chronic inflammatory diseases and play a role in mitigating neurogenic inflammation. It would be a very attractive alternative to nowadays biologics treatment.

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